Diagnostic Performance and Impact of a Multiplex PCR Pneumonia Panel in ICU Patients With Severe Pneumonia.

NCT05624684 | Completed FDA Device

• 1 other identifier: MORICUP-PCR study
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the diagnostic performance of multiplex respiratory PCR (PCR-RM) compared to standard microbiological tests and its potential impact on the early adaptation of antibiotic treatment in intensive care patients with severe pneumonia.

Conditions

Community-acquired Pneumonia; Hospital-acquired Pneumonia; Ventilator Associated Pneumonia

Keywords

Community-acquired Pneumonia; Hospital-acquired Pneumonia; Ventilator Associated Pneumonia; Multiplex PCR; Antibiotic stewardship

Outcome Measures

Primary Outcomes (2)

• The rate of diagnostic concordance between Classical microbiological cultures and the respiratory multiplex PCR (RM-PCR) and conventional microbiological cultures (CMC) to identify pathogens responsible for severe pneumonia in critically ill patients.

  Classical microbiological cultures (CMC) will serve as the gold standard for the comparison between techniques, considering a test result: 1. A true positive, when CMC and RM-PCR have identified the same microorganism (CMC+, PCR-RM +). 2. A false positive, when RM-PCR detected an organism but not CMC (CMC-, RM-PCR+) 3. A true negative, when no method detected any microorganism (CMC-, RM-PCR -) 4. A false negative, when CMC but not RM-PCR has detected an organism (CMC+, RM-PCR -). Sensitivity, specificity, and positive and negative predictive values for the respiratory multiplex PCR will be calculated using the precedent findings.

  through study completion, an average of 6 months

• The impact of the respiratory multiplex PCR (RM-PCR) on the appropriateness of empirical antimicrobial therapy.

  The proportion of patients for whom the respiratory multiplex PCR (RM-PCR) induces an appropriate change of antibiotic therapy. Appropriate changes include adequacy, de-escalation, and escalation of antibiotic treatment. * Adequacy is defined as introducing an antibiotic to cover a microorganism that was not adequately treated before the results of RM-PCR. * Escalation is defined by a widening of the ATB spectrum to cover a pathogen not taken into account or the detection of resistance genes. * De-escalation is defined as the use of a narrower-spectrum anti-infective or the discontinuation of an ATB combination.

  through study completion, an average of 6 months

Study Arms (1)

ICU patients with severe pneumonia

Critically ill patients with severe pneumonia under mechanical ventilation including ventilator-associated pneumonia, community-acquired or hospital-acquired pneumonia.

Diagnostic Test: Multiplex respiratory PCR

Interventions

Multiplex respiratory PCR DIAGNOSTIC_TEST

The BIOFIRE® FILMARRAY® Pneumonia plus Panel

ICU patients with severe pneumonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill patients with ventilator-associated pneumonia (VAP), community-acquired pneumonia (CAP), or hospital-acquired pneumonia (HAP). For CAP and HAP, only patients under invasive mechanical ventilation will be included.

You may qualify if:

• critically ill adult patients
• clinical, biological, and radiological signs of severe pneumonia.
• community-acquired pneumonia, hospital-acquired pneumonia, or ventilator-associated pneumonia
• invasive mechanical ventilation.

You may not qualify if:

• \- Non-invasive mechanical ventilation.

Sponsors & Collaborators

• Avicenna Military Hospital: lead

Study Sites (1)

Avicenna Military Hospital

Marrakesh, Marrakesh Tensift El Haouz, 40000, Morocco

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Cross Infection; Lung Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology and Intensive Care Medicine - Head of surgical intensive care unit

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 22, 2022
• Study Start: February 3, 2023
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: until 5 years after study completion
• Access Criteria: Healthcare workers.

Locations

MO (1)